Associate Engineering Director, Combination Drug Product/Device
Core
Lead the development and lifecycle strategy for drug/device combination products, including prefilled syringes and autoinjectors, serving patients with neurological, psychiatric, endocrine, and immunological disorders.
Role type
Associate Engineering Director, Combination Drug Product/Device
Builds
Injectable delivery systems (prefilled syringes, autoinjectors) and associated packaging for clinical and commercial use.
Domain
Biopharmaceuticals / Medical Devices / Drug Delivery Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug/device combination product development, Design controls, Risk management, Manufacturing scale-up, Technology transfer, cGMP compliance, Global regulatory strategy, External partner management, Human factors engineering
Preferred skills
Regulatory filing support, Commercial launch readiness, Primary container closure systems, Device constituent part control strategies
Technologies
Prefilled syringes, Autoinjectors, Connected health solutions
Responsibilities
Lead strategic planning and execution of drug/device combination product development; Provide technical ownership for delivery devices and packaging; Develop innovative delivery device solutions; Lead technical decision-making and risk management for device integration; Ensure timely completion of development, verification, validation, and technology transfer; Partner with Quality and Regulatory to meet global standards; Manage external partners for device development and manufacturing; Monitor emerging trends in injectable delivery systems.
Seniority
Senior, hands-on IC with leadership responsibilities
